7 deaths, halts phase II clinical trial of MicroGenics
Recently, the death of seven patients in a Phase II trial of MicroGeniccs led to halt the testing. The trial was trying to assess the first line treatment drugs for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The combination of Enoblituzumab with Tebotelimab or Retifanlimab (anti-cancer monoclonal antibodies) was under the assessment as a potential treatment.
The study involved 62 patients out of which 7 died due to hemorrhagic events, confirmed by MicroGenics. Haemorrhage is one of the well known risks of SCCHN but it occurs at a lower rate in comparison to what is observed in phase II trials.
That incidence is between 1% and 3.6%, according to a 2019 study—a range of incidence which, along with a risk-benefit analysis, led to the trial halt, MacroGenics added.
“We were surprised by the emergence of these events in first-line SCCHN patients, as we had not observed any such events in an earlier, smaller study in patients with later-line SCCHN disease who were treated with enoblituzumab in combination with an anti-PD-1 antibody,” said by MacroGenics CEO Scott Koenig.
The news has impacted the overall share performance of the company. There has been an 11% decline in the shares since the announcement of the patient’s death. However, the company is continuing to analyse the data to investigate the situation in detail.